Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-28 @ 8:58 PM
Study NCT ID:
NCT07108257
Status:
RECRUITING
Last Update Posted:
2025-08-06
First Post:
2025-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Resonance-Guided Focused Ultrasound Bilateral Capsulotomy for the Treatment of Refractory Bipolar Depression
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Study Overview
Official Title:
Phase I Trial of Magnetic Resonance-Guided Focused Ultrasound (MRgFUS) Bilateral Capsulotomy for the Treatment of Refractory Bipolar Depression
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate the safety and initial effectiveness of MR-guided focused ultrasound (MRgFUS) bilateral capsulotomy in patients with treatment-resistant bipolar depression (TRBD).
Detailed Description:
This study is a prospective, single arm and nonrandomized phase l study.
Participants will:
* Undergo MRgFUS capsulotomy targeting the anterior limb of the internal capsule.
* Be assessed before and after treatment for adverse events, symptom changes, and quality of life.
* Complete a battery of clinical rating scales including the Hamilton Depression Rating Scale (HAMD), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Young Mania Rating Scale (YMRS), Yale-Brown Obsessive Compulsive Scale (YBOCS), and the Columbia-Suicide Severity Rating Scale (C-SSRS), along with the Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ).
A total of 10 participants, all patients at Sunnybrook Hospital, are expected to enroll in the study. Each participant will be involved for approximately 26 months, including a 2-month pre-treatment period and 24 months of follow-up. The full study duration is estimated at 3 years, with primary results anticipated within 2 to 3 years.
Participants will:
* Undergo MRgFUS capsulotomy targeting the anterior limb of the internal capsule.
* Be assessed before and after treatment for adverse events, symptom changes, and quality of life.
* Complete a battery of clinical rating scales including the Hamilton Depression Rating Scale (HAMD), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Young Mania Rating Scale (YMRS), Yale-Brown Obsessive Compulsive Scale (YBOCS), and the Columbia-Suicide Severity Rating Scale (C-SSRS), along with the Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ).
A total of 10 participants, all patients at Sunnybrook Hospital, are expected to enroll in the study. Each participant will be involved for approximately 26 months, including a 2-month pre-treatment period and 24 months of follow-up. The full study duration is estimated at 3 years, with primary results anticipated within 2 to 3 years.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: